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Comments on Immune-Mediated Adverse Reaction Guidance

[ Price : $8.95]

Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.

Info Collection on Fellowship/Trainee Programs

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Federal Register notice: FDA sends to OMB an information collection extension entitled Conflict-of-Interest Information for Partic...

Independent FDA Needed to Stop Political Meddling: GAO

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A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from political interfere...

Draft Guide on Pulmonary Tuberculosis Drugs

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FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.

Draft Inspection Refusal Guidance

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FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...

FDA Stem Cell Therapy Regulation at Risk: Attorneys

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Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...

Endocrinologic/Metabolic Drugs Panel Renewed

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Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.

United Therapeutics Used Priority Voucher on Tyvaso

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Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics sup...

States Pushing for Canadian Drug Imports: Report

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A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signali...

Drug Promotion Research on Mechanism of Action OKd

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Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Pr...